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A Study of the Safety and Efficacy of Vigam® Liquid in Patients With Primary or Secondary Antibody Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02247154
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Bio Products Laboratory

Brief Summary:

To determine:

  1. The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency (PAD or SAD).
  2. The efficacy of Vigam® Liquid in patients with primary or secondary antibody deficiency.
  3. The half-life of Vigam® Liquid after 4 months of treatment.
  4. The subclass and total gammaglobulin concentrations after each infusion of Vigam® Liquid.

Condition or disease Intervention/treatment Phase
Primary or Secondary Antibody Deficiency Biological: Vigam® (Human Normal Immunoglobulin) Phase 4

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Study of the Safety and Efficacy of an Intravenous Immunoglobulin (Vigam® Liquid) in Patients With Primary or Secondary Antibody Deficiency.
Study Start Date : April 1999
Actual Primary Completion Date : July 2001

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vigam® Liquid Biological: Vigam® (Human Normal Immunoglobulin)



Primary Outcome Measures :
  1. IgG half-life [ Time Frame: Pre-dose, 5 min, 1, 2, 4, 7, 10, 14, 21 days post-dose ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (18-80 years) with PAD or SAD
  • With a low serum IgG (<6 g/l) and a history of recurrent infections
  • Requiring and eligible for polyvalent intravenous immunoglobulin (IVIG) replacement therapy
  • Non-reactive for HBsAg and with an alanine aminotransferase (ALT) level less than twice upper limit of normal prior to entry into the trial

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247154


Locations
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United Kingdom
Papworth Hospital
Papworth Everard, Cambridgeshire, United Kingdom
Cardiff Royal Infirmary
Cardiff, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Royal Brompton Hospital
London, United Kingdom
Royal Free Hospital
London, United Kingdom
Royal Victoria Infirmary
Newcastle, United Kingdom
Hospital of St Cross
Rugby, United Kingdom
Taunton & Somerset Hospital
Somerset, United Kingdom
Sponsors and Collaborators
Bio Products Laboratory

Additional Information:
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Responsible Party: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT02247154     History of Changes
Other Study ID Numbers: VIGPSAD
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs